Celldex Phase II barzolvolimab trial in EoE to be discontinued

Celldex Therapeutics (Nasdaq: CLDX) shares fell as much as 13% on Wednesday, after it posted mixed top-line results from its ongoing Phase II study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.

The New Jersey, USA-based company noted that identifying the key drivers of EoE has challenged the field and research has suggested that mast cells could play an important role in the disease pathogenesis. Celldex designed this study to determine if barzolvolimab could deplete mucosal (intraepithelial) mast cells and, in turn, improve clinical outcomes in EoE.

The primary endpoint of the study, absolute change from baseline to Week 12 in peak esophageal intraepithelial mast cell count was met, but the profound mast cell depletion observed did not result in improvement in EoE symptoms or endoscopic assessment of disease activity compared to placebo. Consistent with previously reported studies, barzolvolimab demonstrated a favorable safety and tolerability profile.